Conference on 4th Annual Contract Manufacturing
11/10/2010

The global demand for contract manufacturing services and affordable outsourcing solutions is increasingly driving the pharmaceutical companies to upgrade their technology and manufacturing capacity.

Online PR News – 10-November-2010 – – Conference on 4th Annual Contract Manufacturing
To be held at 13th – 14th December 2010, Etc venues, Bonhill House, 1-3 Bonhill Street, London, EC2A 4BX, United Kingdom

Key Speakers

Martin P Grosvenor, Drug Delivery Manager, AstraZeneca,
Anthony Pettigrew, Analytical Development Manager, Novozymes,
Olivia Darmuzey, QbD Expert Pharmaceutical Operations, Novartis,
Mitch Rogers, Business Development Manager, Centre for Emergency Preparedness and Response, Health Protection Agency,
Prof. Elaine Martin OBE, Professor of Industrial Statistics, Biopharmaceutical and Bioprocessing, Technology Centre, Newcastle University,
Paul Smith, Validation Program Manager (Europe), PerkinElmer Life and Analytical Sciences,
Karen MacGregor, Product Development Director, Catalent,

The global demand for contract manufacturing services and affordable outsourcing solutions is increasingly driving the pharmaceutical companies to upgrade their technology and manufacturing capacity. In recent times, investments in implementation of PAT and QbD applications, to ensure high quality and timely supply, have become the prime focus of pharmaceutical and biotech industry. As the competition from off-patent products, in-licensing and mergers and acquisitions grows, Asia is expected to become one of the largest cost-effective outsourcing markets in the next five years.

Conference on 4th Annual Contract Manufacturing will provide tactical approaches and case studies to improve PAT and QbD practices for a successful contract manufacturing model. Delegates will learn regulatory and planning processes, best manufacturing practices, and strategies to maximise partnership with CMOs.

Our conference is a valuable opportunity to discuss, gain insights and network with thought leaders and key professionals from the industry.

Key themes and discussions include for Conference on 4th Annual Contract Manufacturing:

Deliver successful external manufacturing supply chain and planning
Learn trends, challenges and opportunities for manufacturing in Asia
Maximise opportunities as a consequence of FDA, PAT and QbD initiatives
Evaluate outsourcing needs your business:
Implement strategies for successful analytical technology transfer
Analyse critical issues affecting technology transfer & scale-up to QC
Understand QbD principles and continuous improvement in manufacturing
Capitalise on the benefits of applying QbD approach in biologics contract manufacturing
Formulate strategies to choose a right CMO partner
Integrate lean product development in a pharma CMO set-up
Understand the legal challenges and pitfalls for contract negotiation

Conference on 4th Annual Contract Manufacturing Introduction

Learn, discuss and gain insights on:

Deliver successful external manufacturing supply chain and planning.
Learn trends, challenges and opportunities for manufacturing in Asia.
Maximise opportunities as a consequence of FDA, PAT and QbD initiatives.
Evaluate outsourcing needs your business.
Implement strategies for successful analytical technology transfer.
Analyse critical issues affecting technology transfer & scale-up to QC.
Understand QbD principles and continuous improvement in manufacturing.
Capitalise on the benefi ts of applying QbD approach in biologics contract manufacturing.
Formulate strategies to choose a right CMO partner.
Integrate lean product development in a pharma CMO set-up.
Understand the legal challenges and pitfalls for contract negotiation.

Who will be there for Conference on 4th Annual Contract Manufacturing?

Directors, Heads of Department, Team Leaders and Scientists of:
Research and Development.
PAT.
QbD.
CMC.
Process Development & Optimisation.
Process Science/ Analytics.
Manufacturing.
Contracts & Outsourcing.
Formulation.
Quality Assurance/Quality Control.
Operations.
Strategic Alliances.
Compliance.
Regulatory Affairs.
Legal/ Patents.

Pharmaceutical and Biotechnological Companies,
Contract Manufacturing Organisations (CMOs),
Drug Regulators, Intellectual Property/Law Firms,
Academia, Government Bodies, Regulatory Affairs.

Day 1
Conference on 4th Annual Contract Manufacturing Monday 13th December 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Applying QbD for the development and manufacture of new products

Achieving QbD objectives
QbD and continuous improvement in manufacturing
The use of MVDA models to ensure quality compliance in routine production

Olivia Darmuzey
QbD Expert - PharmOps CH, Novartis Pharma

10:20 Identifying and exploiting opportunities from Process Analytical Technology (PAT)
Exploiting on-line process analytical measurements to gain insight into process performance
Making maximum use of a limited number of data sets in the CMO environment
Techniques to interpret data from instrumentation to assess on-line process quality
Skills required to maximise the benefits of PAT

Prof Elaine Martin OBE
Professor of Industrial Statistics, Biopharmaceutical and Bioprocessing Technology Centre, Newcastle University
Prof Gary Montague
Professor of Bioprocess Control, Biopharmaceutical and Bioprocessing Technology Centre, Newcastle University

11:00 Morning refreshments

11:20 Continuous manufacturing for oral solid dosage tablet making PAT application

PAT as the key enabler to achieve QbD by means of ‘Model Predictive Control’ and ‘Real Time Product Release’
How to deal with tracking and tracing when going from a batch to a continuous process?
Benefits of continuous processes in commercial manufacturing and late stage product development

Rebecca Vangenechten
Consultant - Business & Project Development Life Sciences, USA, Siemens Industry & Automation

12:00 GMP Critical Utilities from A to Z

Design of pharmaceutical water and steam systems
Quality control during erection
Commissioning
Qualification (IQ & OQ)
Validation (PQ)
Daily operation and sampling
Change control
Re-qualification

Henrik Goldschmidt
Proceskonsulent, GPE Consult

12:40 Networking lunch

13.40 The role of the analytical laboratory in technology transfer

Common problems,
Transfer strategy,
Planning the transfer
Case studies and learning.

Paul Smith
Validation Program Manager (Europe), PerkinElmer Life and Analytical Sciences

14:20 From test tube to tank

Critical issues affecting technology transfer & scale-up
Addressing issues surrounding high containment manufacturing
cGMP production: Therapeutic products of prokaryote fermentation

Mitch Rogers
Business Development Manager, Health Protection Agency

15:00 Afternoon refreshments

15:20 Validation, stability and method transfer activities to QC and contract manufacturers

Develop and validate new analytical test methodologies
Strategy and design for methods and complex investigations
Identifying quality or safety issues

Anthony Pettigrew,
Analytical Development Manager, Novozymes

16:00 Risk mitigation strategies and IP challenges

Discussing the rules and regulations that apply specifically to the UK
Using UK regulations in the evaluation process
IP barriers and challenges

16:40 Closing remarks from the chair.

Day 2
Conference on 4th Annual Contract Manufacturing Tuesday 14th December 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Is outsourcing manufacture right for your business?

Defining the strategic direction of the pharma company
Risks and benefits of outsourcing
Impact of outsourcing on marketplace and pharma company
Manufacture of commodity products
Manufacture of products using proprietary technologies
Assessing value benefits in cost, time and quality

Martin P Grosvenor,
Drug Delivery Manager. AstraZeneca

10:20 Contract manufactures: Quality is more than an audit

Traditional procurement quality
Customer: Supplier approach isn’t effective
Relationship management
Understanding each other

Nigel Cryer
Interim Head, Global Quality Manufacturing & Supply Chain, Norgine,

11:00 Morning refreshments

11:20 Custom manufacturing: Sourcing APIs in emerging markets

What are the commercial implications of increasing globalisation of the API contract manufacturing market?
API supplier identification and negotiations
Market evolution: Regulatory compliances, new patent laws, decreasing number of NCEs

Laurent Pinchard
Director – EU Operations (API), Glenmark Generics

12:00 Emerging markets: CMO outsourcing

Understanding the influence of global regulatory culture on establishing outsourcing projects
Indentifying lucrative opportunities and establishing strategic alliances in emerging markets to minimise costs
Legal and intellectual property challenges in negotiating contracts and managing relationships.

12:40 Networking lunch

13:40 CMO management throughout the lifecycle
Establish and improve relationship management practices with strategically important CMOs
The process: Plan, select, negotiate, implement and manage
Governance plan
Expected deliverables

Nelson M Lugo
Sr. Director, Contract Manufacturing, Amylin Pharmaceuticals

14:20 Achieving product traceability with pharmaceutical packaging

Cost effective and integrated processing for packaging
Operational challenges in working with 3rd party contract manufacturers
Pack design/process & reproducibility

15:00 Afternoon refreshments

15:20 Globalisation in manufacturing: In-house production vs Outsourcing
Our expert panel will discuss and debate on the need for outsourcing, indentifying opportunities and operational challenges to work with third party contractors
Panel members will be drawn from the speakers who take part on day one or day two.

16:00 Lean product development in a pharma CMO set-up

Evaluation of the economic, financial and technical needs to drive a lean mentality within product development
How to achieve, optimise & continually support an integrated approach for implementing lean product development?
Review of case studies as to the benefits realised from both CMOs and pharmaceutical companies using a lean approach

Karen MacGregor
Product Development Director, Catalent

16:40 Chair’s closing remarks

16:50 End of conference.